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Class 2 Device Recall Mentor MemoryGel Breast Implant |
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Date Initiated by Firm |
July 01, 2016 |
Create Date |
August 03, 2016 |
Recall Status1 |
Terminated 3 on December 09, 2016 |
Recall Number |
Z-2326-2016 |
Recall Event ID |
74565 |
PMA Number |
P030053 |
Product Classification |
Prosthesis, breast, noninflatable, internal, silicone gel-filled - Product Code FTR
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Product |
Mentor MemoryGel Breast Implant; Indicated for females for breast augmentation and breast reconstruction. |
Code Information |
7316994 |
Recalling Firm/ Manufacturer |
Mentor Texas, LP. 3025 Skyway Cir N Irving TX 75038-3524
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For Additional Information Contact |
Customer Service 800-235-5731
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Manufacturer Reason for Recall |
The box of 300cc MemoryGel Breast Implant was labeled with null manufacturing and expiration dates.
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FDA Determined Cause 2 |
Labeling mix-ups |
Action |
The affected consignees were notified via customer letter on 7/1/16, and a follow-up with respective sales representative via visit. |
Quantity in Commerce |
35 units |
Distribution |
Distributed in the states of NY, WI, CA, TX, CO, NC, NJ, OH, TN, RI, and IL. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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PMA Database |
PMAs with Product Code = FTR and Original Applicant = MENTOR CORP.
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